Injuries of the intra-articular and extra-articular tissues, including all ligaments and tendons injuries, such as injuries of the anterior cruciate collateral ligament (ACL), posterior cruciate ligament, rotator cuff tendon, Achilles tendon, meniscus and articular cartilage present numerous clinical problems. These tissues are unable to heal spontaneously and often fail to heal following the currently available treatments and surgical repair and reconstructions procedures.
Quite a few novel approaches, such as bioengineering of the new ligament or tendon, were recently described. For example, US application 2002/0062151 published on May 23, 2002 describes a method for producing an anterior cruciate ligament ex vivo; US application 2003/0100108 published on May 29, 2003 describes a matrix for production of tissue engineered ligaments for production of tissue engineered ligaments; US application 2003/0100108 published on May 29, 2003 describes a matrix for production of tissue engineered ligaments, tendons and other tissues ex vivo; U.S. Patent application 2004/0219659 published on Nov. 4, 2004 describes a bioreactor system for providing physiologically relevant translational and rotational strains of a growing bioengineered tissue, such as for example, ligament; U.S. Patent application 2004/0224406 published on Nov. 11, 2004 describes immunoneutral silk-fiber-based medical devices useful to form fabric for formation of tissue-supporting devices for implantation.
However, all these approaches are directed toward production of the new tissues ex vivo and it would thus be advantageous to have available methods for repair and reconstruction of ligaments and tendons in vivo and in situ settings.
Novel approaches to the repair and reconstruction of the articular cartilage have been previously described by inventors in, for example, U.S. Pat. No. 6,949,252, issued on Sep. 27, 2005, or the U.S. patent applications Ser. No. 10/625,245, filed on Jul. 22, 2003; Ser. No. 10/625,822, filed on Jul. 22, 2003; Ser. No. 10/882,581 filed on Jun. 30, 2004, allowed; Ser. No. 10/626,459, filed on Jul. 22, 2003; Ser. No. 10/921,389, filed on Aug. 18, 2004 and Ser. No. 10/998,230, filed on Nov. 24, 2004, issued as the U.S. Pat. No. 7,157,428 on Jan. 2, 2007, all hereby incorporated by reference.
The issued patents and applications disclose suitable adhesive sealants, materials suitable to be used as a support matrix, materials suitable for preparation of the supporting sleeves and methods for open, arthroscopic, or arthroscopic assisted surgical procedures similar to those involved in the current invention. All methods and materials disclosed in these patents and applications are hereby incorporated by reference to the extent that they are applicable to the current invention.
The current invention concerns a novel method for treatment and repair and reconstruction of the ligament and tendon injuries, tears or ruptures by utilizing biologically acceptable tissue adhesives that enable a fixation of the ruptured ligaments and tendons in a stable juxtaposition and promote their healing in situ as well as providing a means for protecting the treated site in situ for a period of time needed for healing. One advantage of this approach is that the ruptured or injured ligaments or tendons need not be partially or completely removed and replaced with the engineered ligaments or tendons, as described in the above-cited publications. Such replacement is an intricate process and an attachment of the replacement ligaments or tendons to the bones or muscles requires rather complicated surgical procedures.
The current invention provides conditions for treatment of the ligament or tendon injuries and tears in situ by permitting, during open, arthroscopic or arthroscopic assisted surgical procedures to find the loose frayed edges of the ruptured ligaments or tendons, and insofar as possible, fix these edges with a tissue adhesive in a stable juxtaposition similar to that found in the healthy tissue. Following the fixation with the tissue adhesive, the tear or rupture covered with and sealed with the adhesive is protected by the protective biodegradable sleeve optionally also containing a support matrix with or without exogenously added cells, such as, fibrocytes, tenocytes, progenitor, embryonic or stem cells, and additionally optionally supplemented with growth promoting factors, modulators or other agents added to the adhesive or embedded within the supporting matrix. The biodegradable time of the tissue adhesive and/or of the protective sleeve is designed to be at least as long as and/or to correspond to the time needed for healing.
All patents, patent applications and other publications disclosed herein are hereby incorporated by reference.